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Provocholine Inhalation Solution Methacholine Chloride 48 mg/3mL Solution — NDC 64281-0116-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Provocholine Inhalation Solution Methacholine Chloride 48 mg/3mL Solution — NDC 64281-116-12 (Billing 64281-0116-12)

by Methapharm Inc. · 2 CARTON in 1 CARTON / 6 VIAL, PLASTIC in 1 CARTON / 3 mL in 1 VIAL, PLASTIC

This is a package of Provocholine Inhalation Solution Methacholine Chloride 48 mg/3mL Solution from Methapharm Inc., marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 64281-0116-12
🏷️ FDA NDC (as labeled) 64281-116-12 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64281-116-12
Product NDC 64281-116
11-digit billing NDC 64281011612
UNII 0W5ETF9M2K
Application # NDA019193
SPL Set ID e8983096-65e6-41f2-8b6f-bbf0a7227307
Established class (EPC) Cholinergic Receptor Agonist
Mechanism of action Cholinergic Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-14
Route RESPIRATORY (INHALATION)
Dosage form SOLUTION
Substance METHACHOLINE CHLORIDE
Why two NDCs? The FDA registers this code as 64281-116-12 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 64281-0116-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
64281-0116-12 You're viewing this Main listing 2 CARTON in 1 CARTON / 6 VIAL, PLASTIC in 1 CARTON / 3 mL in 1 VIAL, PLASTIC 2026-04-14 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Provocholine Inhalation Solution 48 mg/3mLthis 64281-0116-12 Methapharm 6 vials — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 4550K0SC9B
    Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.

2 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerMethapharm Inc.
Application holderMETHAPHARM INC
FDA applicationNDA019193 (NDA)
Labeler code64281
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning ~1 min read ▾

WARNING: SEVERE BRONCHOCONSTRICTION WARNING: SEVERE BRONCHOCONSTRICTION Severe bronchoconstriction can result from Provocholine administration (including the lowest dose). The use of Provocholine is contraindicated in pediatric and adult patients with baseline FEV1 < 60% predicted or adults with FEV1 <

1.5L. Because of the potential for severe bronchoconstriction, the use of Provocholine in patients with clinically apparent asthma or wheezing is not recommended [ see Warnings and Precautions (5.1) ]. Emergency equipment and medication should be immediately available to treat acute respiratory distress.

If severe bronchoconstriction occurs, reverse immediately with a rapid-acting inhaled bronchodilator agent (β-agonist) [ see Warnings and Precautions (5.1) ]. If baseline spirometry is not performed or is measured inaccurately, the initial FEV1 may be underestimated. In this situation, decreases in FEV1 may not be detected after administration of escalating Provocholine doses, which may result in administration of unnecessary higher doses and an increased risk for excessive bronchoconstriction [ see Warnings and Precautions (5.1) ].

WARNING: SEVERE BRONCHOCONSTRICTION See full prescribing information for complete boxed warning. Severe bronchoconstriction can result from Provocholine administration (including the lowest dose) (5.1) Use of Provocholine is contraindicated in pediatric and adult patients with baseline FEV1 < 60% predicted or adults with FEV1 <

1.5L (5.1) Use of Provocholine is not recommended in patients with clinically apparent asthma or wheezing (5.1) If severe bronchoconstriction occurs, reverse immediately with a rapid-acting inhaled bronchodilator agent (β-Agonist) (5.1)

🎯 Indications and Usage 76 words ▾

1 INDICATIONS AND USAGE Provocholine, used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma. Provocholine, a cholinergic agonist used in a methacholine challenge test, is indicated for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients five years of age and older who do not have clinically apparent asthma (1)

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION The methacholine challenge test should be conducted in a pulmonary function laboratory or clinic, by adequately trained personnel, for safety and accuracy (2.1) Determine baseline FEV1 values to assess whether a patient is able to undergo the methacholine challenge test (2.1) See the Full Prescribing Information for the required reconstitution and dilution procedures prior to use (2.2). Recommended dosage(s) of Provocholine in the Methacholine Challenge Test is administration of increasing strengths of Provocholine solution via nebulization (2.3) Administer using either the 5-Breath Dosimeter Dosing Method or the 1-Minute Tidal Breathing Dosing Method with the doubling or quadrupling stepwise protocols (2.4, 2.5) See the full Prescribing Information for administration of inhaled β-agonist after Methacholine Challenge Test (2.6) See the Full Prescribing Information for the interpretation of the results and calculation of hyperresponsiveness (2.7)

2.1Preparation and Administration Overview Provocholine powder for inhalation solution requires reconstitution and dilution prior to use [see Dosage and Administration (2.2)]. Provocholine inhalation solution in a ready-to-use kit does not require reconstitution and/ or silution prior to use. Provocholine inhalation solution 16 mg/mL in a single-dose vial requires dilution prior to use [see Dosage and Administration (2.2)] .

For safety and accuracy, administer Provocholine during a methacholine challenge test in a pulmonary function laboratory or clinic, by an adequately trained personnel. Only healthcare providers trained in and thoroughly familiar with all aspects of the test’s technique and management of respiratory distress should perform the test. Emergency medication and equipment should be immediately available to treat acute respiratory distress.

Consider Provocholine use in patients on chronic asthma drugs if the accuracy of the asthma diagnosis is in doubt. In these patients, only administer Provocholine if spirometry is normal after supervised withdrawal of the asthma drugs. Provocholine is not recommended for use in patients with clinically apparent asthma or wheezing.

Before starting a methacholine challenge test, baseline spirometry must be performed. For a patient to be able to undergo the test, he or she must present with baseline FEV 1 (Forced Expiratory Volume in 1 second) greater than or equal to 60% of the predicted value (in adults and children) and greater than or equal to

1.5L (in adults). Provocholine is contraindicated in adult and pediatric patients with baseline FEV1 < 60% predicted or in adults with FEV 1 <

1.5L [see Contraindications (4) and Warnings and Precautions (5.1)]. At commencement of the methacholine challenge test and prior to administration of Provocholine, a post-diluent FEV 1 must be measured following nebulization of the diluent or base solution (contains no methacholine chloride) [ see Dosage and Administration (2.4, 2.5)]. Administer Provocholine by oral inhalation, with or without food, using either the 5-Breath Dosimeter Dosing Method or the 1-Minute Tidal Breathing Dosing Method with the dose doubling or quadrupling protocols [see Dosage and Administration (2.3, 2.4, 2.5)].

Discard any unused solution from the nebulizer after each administration. The methacholine challenge test is considered positive if there is a reduction of FEV 1 of 20% or more from the post-diluent FEV 1 . The test should be stopped at this point.

Calculate and record the FEV 1 reduction value before starting the test [see Dosage and Administration (2.3, 2.4, 2.5)]. After the methacholine challenge test with Provocholine, administer an inhaled β-agonist to expedite the return of the FEV 1 to baseline and to relieve any discomfort the patient may experience. Most patients revert to normal pulmonary function within 10 to 20 minutes following administration of an inhaled β-agonist [see Dosage and Administration (2.6)].

2.2 Reconstitution an…

💊 Dosage Forms and Strengths 211 words ▾

3 DOSAGE FORMS AND STRENGTHS • For inhalation solution: 100 mg of methacholine chloride crystalline powder, white to off-white in color in amber glass vials (powder is reconstituted and then diluted prior to administration) • Inhalation solution ready-to-use (sterile): Contain the following strengths of methacholine chloride in a clear, colorless solution. i. 3 mL base solution (contains no methacholine chloride) ii. 0.0625 mg/mL (0.1875 mg/ 3 mL) of methacholine chloride iii.

0.25mg/mL (0.75 mg/ 3 mL) of methacholine chloride iv. 1 mg/mL (3 mg/ 3 mL) of methacholine chloride v. 4 mg/mL (12 mg/ 3 mL) of methacholine chloride vi.

16 mg/mL (48 mg/ 3 mL) of methacholine chloride • Inhalation solution (in a single-dose vial): 16 mg/mL (48 mg/ 3 mL) of methacholine chloride in a clear, colorless solution in a 3 mL plastic single-dose vial with a twist-off cap. • For inhalation solution: 100 mg of methacholine chloride powder in amber glass vial (3) • Inhalation solutions: o Ready-to-use-kit: base solution (contains no methacholine chloride), 0.0625 mg/mL (0.1875 mg/3 mL), 0.25 mg/mL (0.75 mg/3 mL), 1 mg/mL (3 mg/ 3mL), 4 mg/mL (12 mg/3 mL), and 16 mg/mL (48 mg/3 mL) of methacholine chloride (3) o Single-dose vial: 16 mg/mL (48 mg/3 mL) of methacholine chloride (3) -----------------------------

⛔ Contraindications 65 words ▾

4 CONTRAINDICATIONS Provocholine is contraindicated in patients with: Hypersensitivity to methacholine or other parasympathomimetic agents. Reactions have included rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Baseline FEV 1 < 60% predicted (adults or pediatric patients) or <1.5 L (adults) hypersensitivity to methacholine chloride or other parasympathomimetic agents (4) Baseline FEV 1 <60% predicted (adults or pediatric patients) or <1.5 L (adults) (4)

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS . Risk of Severe Bronchoconstriction: Severe bronchoconstriction can result from Provocholine administration. Do not use Provocholine in pediatric and adult patients with baseline FEV1 <60% predicted or adults with FEV1 <1.5 L.

Not recommended in patients with clinically apparent asthma or wheezing. If severe bronchoconstriction occurs, reverse with administration of rapid-acting inhaled β2-agonist. (5.1) • Bronchoconstriction from Inadvertent Exposure: Healthcare provider and any other personnel involved in the administration of the methacholine challenge test should take precautions to avoid inadvertent inhalation of Provocholine powder and nebulized aerosol (5.2) • Risk in Patients with Coexisting Diseases and Conditions: Provocholine not recommended for patients with uncontrolled hypertension, aortic aneurysm, or history of myocardial infarction or stroke diseases.

Consider the benefits and potential risk for use of Provocholine in patients with conditions that could be adversely affected by a cholinergic agent. (5.3)

5.1Risk of Severe Bronchoconstriction Severe bronchoconstriction can result from Provocholine administration (including the lowest dose). The use of Provocholine is contraindicated in pediatric and adult patients with baseline FEV 1 < 60% predicted or adults with FEV 1 <

1.5L. Emergency equipment and medication should be immediately available to treat acute respiratory distress. Because of the potential for severe bronchoconstriction, the use of Provocholine in patients with clinically apparent asthma or wheezing is not recommended.

If severe bronchoconstriction occurs, reverse immediately by the administration of a rapid-acting inhaled β-agonist. If baseline spirometry is not performed or is measured inaccurately, the initial FEV 1 may be underestimated. In this situation, decreases in FEV 1 may not be detected after escalating Provocholine doses, which may result in administration of unnecessary higher doses and an increase in the risk for excessive bronchoconstriction.

5.2Bronchoconstriction from Inadvertent Exposure to Healthcare Providers Administering Provocholine The supplied Provocholine powder or the Provocholine nebulized aerosol may cause bronchoconstriction in healthcare providers administering Provocholine in a methacholine challenge test. Healthcare providers and any other personnel involved in the administration of Provocholine should take the following precautionary steps: Do not inhale the supplied Provocholine powder Do not handle the Provocholine powder if you have asthma or hay fever.

Apply a low resistance filter to expiratory ports of dosing apparatus, as necessary, to prevent Provocholine release in the room air

5.3Risk in Patients with Coexisting Diseases and Conditions Provocholine is not recommended for patients with uncontrolled hypertension, aortic aneurysm, or history of myocardial infarction or stroke diseases. Patients with epilepsy, vagotonia, peptic ulcer disease, thyroid disease, urinary tract obstruction or other condition that could be adversely affected by a cholinergic agent should undergo methacholine challenge only if the healthcare practitioner considers the benefit to the individual outweighs the potential risks.

🤒 Adverse Reactions 104 words ▾

6 ADVERSE REACTIONS The following adverse reactions associated with the use of Provocholine were identified in clinical studies or post marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Respiratory System: Bronchospasm (includes symptoms such as chest tightness, cough or wheezing).

Less Common Adverse Reactions: Headache, throat irritation, light-headedness and itching. Adverse reactions are bronchoconstriction, headache, throat irritation, light-headedness, and itching (6) To report SUSPECTED ADVERSE REACTIONS, contact Methapharm at 1-866-701-4636 or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch

🔄 Drug Interactions 150 words ▾

7 DRUG INTERACTIONS Beta-Adrenergic Blockers The use of beta-adrenergic blockers may impair reversal of Provocholine-caused bronchoconstriction. Beta-Agonists, Anticholinergics, and Theophylline Beta-agonists, anticholinergics, and theophylline inhibit the response of airways to Provocholine; therefore, hold these drugs before Provocholine use for the following duration: • Short-acting β-agonists (e.g., albuterol): 6 hours • Long-acting β-agonists (e.g., salmeterol): 36 hours • Short-acting anti-cholinergics (e.g., ipratropium): 12 hours • Long-acting anti-cholinergics (e.g., tiotropium): ≥168 hours • Oral theophylline: 12-48 hours Oral or Inhaled Corticosteroids, and Inhaled Cromoglycate Regular use of oral or inhaled corticosteroids and inhaled cromoglycate may acutely decrease bronchial responsiveness to Provocholine.

However, these drugs may be continued with Provocholine use. Beta-Adrenergic Blockers : May impair reversal of Provocholine-caused bronchoconstriction (7) Beta-Agonists, Anticholinergics, and Theophylline : Inhibit response to Provocholine; therefore, hold these drugs prior to Provocholine use (7) Oral or Inhaled Corticosteroids, and Inhaled Cromyoglycate : May decrease response to Provocholine (7)

👥 Use in Specific Populations ~1 min read ▾

8 USE IN SPECIFIC POPULATIONS . Pregnancy: Provocholine is not recommended (8.1)

8.1Pregnancy Risk Summary The available data from published literature on Provocholine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies evaluating effects of methacholine chloride on embryofetal development have not been conducted. Diagnosis of bronchial airway hyperreactivity with bronchoprovocation challenge is not recommended for pregnant women because of the potential for hypoxia in the fetus.

If bronchial airway hyperreactivity is suspected, consider trial of empiric treatment. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

8.2Lactation Risk Summary There are no available data on the presence of methacholine chloride in human milk, the effect on the breastfed infant, or the effect on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Provocholine and any potential adverse effects on the breastfed infant from Provocholine or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of Provocholine used in a methacholine challenge test, has been established for the diagnosis of bronchial airway hyperreactivity in pediatric patients 5 years of age and older who do not have clinically apparent asthma. The safety and effectiveness of Provocholine have not been established in pediatric patients younger than 5 years of age.

8.5Geriatric Use The diagnosis of bronchial airway hyperreactivity is largely performed in pediatric and younger adult patients. Clinical studies of Provocholine did not include patients 65 years of age or older.

🤰 Pregnancy 143 words ▾

8.1Pregnancy Risk Summary The available data from published literature on Provocholine use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies evaluating effects of methacholine chloride on embryofetal development have not been conducted. Diagnosis of bronchial airway hyperreactivity with bronchoprovocation challenge is not recommended for pregnant women because of the potential for hypoxia in the fetus.

If bronchial airway hyperreactivity is suspected, consider trial of empiric treatment. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

🧒 Pediatric Use 60 words ▾

8.4Pediatric Use The safety and effectiveness of Provocholine used in a methacholine challenge test, has been established for the diagnosis of bronchial airway hyperreactivity in pediatric patients 5 years of age and older who do not have clinically apparent asthma. The safety and effectiveness of Provocholine have not been established in pediatric patients younger than 5 years of age.

🧓 Geriatric Use 32 words ▾

8.5Geriatric Use The diagnosis of bronchial airway hyperreactivity is largely performed in pediatric and younger adult patients. Clinical studies of Provocholine did not include patients 65 years of age or older.

🧬 Clinical Pharmacology 80 words ▾

12 CLINICAL PHARMACOLOGY .

12.1Mechanism of Action Methacholine chloride is a cholinergic agonist. Bronchial smooth muscle contains significant parasympathetic (cholinergic) innervation. Methacholine chloride agonizes the muscarinic receptors which eventually induce bronchoconstriction.

12.2Pharmacodynamics After oral inhalation of Provocholine, patients with asthma are more sensitive to Provocholine-induced bronchoconstriction than are healthy subjects. This difference in response is the pharmacological basis for Provocholine in the methacholine challenge test.

12.3Pharmacokinetics There are no metabolic and pharmacokinetic data available on methacholine chloride.

🧬 Mechanism of Action 28 words ▾

12.1Mechanism of Action Methacholine chloride is a cholinergic agonist. Bronchial smooth muscle contains significant parasympathetic (cholinergic) innervation. Methacholine chloride agonizes the muscarinic receptors which eventually induce bronchoconstriction.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Provocholine (methacholine chloride) for Inhalation Solution: Powder: 100 mg of methacholine chloride as a white to off-white powder in amber glass vial. Each carton contains six vials (NDC 64281-100-06). Store the supplied powder at 59°F to 86°F (15°C to 30°C).

Provocholine (methacholine chloride) Inhalation Solution: Provocholine Inhalation Solution Ready-to-use kits are supplied in two formats: 1. Each carton contains six sterile ready-to-use kits (NDC: 64281-110-06). Each sterile ready-to-use kit (NDC 64281-110-05) contains six plastic vials with twist-off cap.

Each vial contains 3 mL of different strengths of methacholine chloride in a clear, colorless solution as follows: a) base solution (contains no methacholine chloride) (NDC 64281-111-00) b) 0.0625 mg/mL (0.1875 mg/3 mL) (NDC 64281-112-00) c) 0.25 mg/mL (0.75 mg/3 mL) (NDC 64281-113-00) d) 1 mg/mL (3 mg/3 mL) (NDC 64281-114-00) e) 4 mg/mL (12 mg/3 mL) (NDC 64281-115-00) f) 16 mg/mL (48 mg/3 mL) (NDC 64281-116-00) 2. Each carton contains six sterile ready-to-use kits (NDC: 64281-110-06). Each sterile ready-to-use kit (NDC 64281-110-05) contains six foil pouches.

Each foil pouch contains a 3 mL plastic vial (with twist-off cap) of different strengths of methacholine chloride in a clear, colorless solution as follows: g) base solution (contains no methacholine chloride) (NDC 64281-111-00) h) 0.0625 mg/mL (0.1875 mg/3 mL) (NDC 64281-112-00) i) 0.25 mg/mL (0.75 mg/3 mL) (NDC 64281-113-00) j) 1 mg/mL (3 mg/3 mL) (NDC 64281-114-00) k) 4 mg/mL (12 mg/3 mL) (NDC 64281-115-00) l) 16 mg/mL (48 mg/3 mL) (NDC 64281-116-00) Provocholine Inhalation Solution Single-dose Vial: 16 mg/mL of methacholine chloride in a clear, colorless solution in a 3 mL plastic single-dose vial with twist-off cap in two formats: 1.

Each outer carton contains two inner cartons (NDC 64281-116-12). Each inner carton contains six vials of 16 mg/mL solution (NDC 64281-116-06). 2.

Each carton contains three foil pouches each containing cards of four plastic 3 mL vials containing 16 mg/mL of methacholine chloride (NDC 64281-116-12). Store ready-to-use kits and single-dose vials between 15°C to 25°C (59°F to 77°F). Use immediately upon opening the vial.

📋 Description ~1 min read ▾

11 DESCRIPTION Methacholine chloride, the active ingredient of Provocholine, is a parasympathomimetic (cholinergic) bronchoconstrictor agent. Provocholine (methacholine chloride) powder for solution is administered by oral inhalation. Chemically, methacholine chloride (the active ingredient) is 1-propanaminium, 2-(acetyloxy)-N,N,N,-trimethyl-, chloride.

It is a white to practically white deliquescent compound, soluble in water, alcohol and chloroform and insoluble in ether. Aqueous solutions are neutral to litmus. Methacholine chloride has an empirical formula of C 8 H 18 ClNO 2 , a molecular weight of 195.69, and the following structural formula: Provocholine (methacholine chloride) for Inhalation Solution: Each vial of Provocholine contains 100 mg of methacholine chlodide powder Provocholine (methacholine chloride) Inhalation Solution: • Ready-to-use kit (sterile): Plastic vials with twist-off cap containing 3 mL of the following strengths of methacholine chloride solution.

Each solution also contains the following inactive ingredients: sodium acetate trihydrate, sodium chloride, water for injection. Glacial acetic acid is added to adjust pH. a) base solution (contains no methacholine chloride) b) 0.0625 mg/mL (0.1875 mg/3 mL) c) 0.25 mg/mL (0.75 mg/3 mL) d) 1 mg/mL (3 mg/3 mL) e) 4 mg/mL (12 mg/3 mL) f) 16 mg/mL (48 mg/3 mL) • Single-dose plastic vial with twist off cap containing 16 mg/mL (48 mg/3mL) of methacholine chloride solution. Solution also contains the following inactive ingredients: sodium acetate trihydrate, sodium chloride, and water for injection.

Glacial acetic acid is added to adjust pH. structure

💬 Information for Patients 61 words ▾

17 PATIENT COUNSELING INFORMATION Risk of Severe Bronchoconstriction Inform the patient or caregiver that severe bronchoconstriction can result from Provocholine administration [see Warnings and Precautions (5.1)] . Methapharm, Inc. 8230 210th Street #109 Boca Raton, FL, USA 33433 For more information visit www.methapharmrespiratory.com, email [email protected] or call 1-833-887-7686. ® Provocholine is a registered trademark of Methapharm Inc.

Revision: July 2026 methapharm

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Provocholine Inhalation Solution (this brand).

Top reported reactions

Vomiting1

Reporter sex

1 reports
Female · 100%
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Methapharm Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Methapharm Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 64281-0110-06 · Methapharm 64304-4304-01 · McKinley →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.